# K202628: Disposable Medical Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Qinghai Zhong Dao Win-Win Medical Protective Equipment Co.,
- Decided: Mar 19, 2021 after 189 days
- Product code: FXX (Mask, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K970835 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173062: Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)), V&Q Manufacturing Corporation (2018) Summary page 4.

## Indications for use
The Disposable medical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This is a single use, disposable device(s), provided non-sterile.

Source page: https://510kreport.com/device/K202628
Methodology: https://510kreport.com/methodology